safety, tolerability and immune response of imvamune (mva-bn)smallpox vaccine in patients with atopic disorders

Conditions: Dermatitis, Atopic; Hay Fever

Summary: the purpose of this study is to gather information on the safety and immunogenicity of an investigational smallpox vaccine in populations with atopic disorders.


Eligibility criteria:
inclusion criteria: all subjects * age 18-40. * read, signed and dated informed consent. * women of childbearing potential must use an acceptable method of contraception group 1: healthy subjects * no history of atopic dermatitis as documented in the patient file * no active atopic dermatitis * no other atopic disorders such as asthma or allergic rhinitis. * prick test without clinical significance * ige within normal range group 2: subjects with history of atopic dermatitis group 3: subjects with mild active atopic dermatitis - scorad 1 - 15. group 4: subjects with mild allergic rhinitis * at least one active allergic rhinitis phase during last year. exclusion criteria: * known or suspected history of smallpox vaccination or typical vaccinia scar. * positive test result in mva specific elisa at screening. * positive result in hiv or hcv antibody test at screening. * surface antigen of hepatitis b virus (hbsag) positive at screening. * pregnant or breast-feeding women. * positive pregnancy test at screening and/or within 24 hours prior to vaccination. * alanine aminotransferase (alt) or aspartate aminotransferase (ast) above the institutional upper limit of normal. * positive urine glucose by dipstick or urine analysis. * inadequate renal function defined as a serum creatinine above the institutional upper limit of normal; urine protein \>30 mg/dl or trace proteinuria (by urine analysis or dipstick); and a calculated creatinine clearance \<80 ml/min. * electrocardiogram (ecg) with clinical significance. * hemoglobin \<11 g/dl; white blood cells less than 2,500 and more than 11,000/mm3; platelets less than 140,000/mm3. * uncontrolled serious infection i.e. not responding to antimicrobial therapy. * history of any serious medical condition, which in the opinion of the investigator would compromise the safety of the subject. * history of or active autoimmune disease. * known or suspected impairment of immunologic function including, but not limited to, clinically significant liver disease; diabetes mellitus; moderate to severe kidney impairment. * history of malignancy. * history or clinical manifestation of clinically significant mental illness or haematological, renal, hepatic, pulmonary, central nervous, cardiovascular or gastrointestinal disorders. * any condition which might interfere with study objectives. * history of immunodeficiency. * history of myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, or other heart condition under the care of a doctor. * three or more of the following risk factors: high blood pressure, high blood cholesterol, diabetes mellitus or high blood sugar, a first degree relative who had a heart condition before the age of 50, smoking cigarettes. * history of chronic alcohol abuse and/or intravenous drug abuse. * history of allergic reactions likely to be exacerbated by any component of the vaccine. * history of anaphylaxis or severe allergic reaction. * acute disease (illness with or without a fever) at the time of enrollment. * any vaccinations within a period starting 30 days prior to administration of the vaccine and ending at study conclusion. * chronic administration of immuno-suppressant or immune-modifying drugs. * post organ transplant subjects whether or not receiving chronic immunosuppressive therapy. * administration or planned administration of immunoglobulins and/or any blood -- use of any investigational or non-registered drug. * blood donation 8 weeks in advance or during study participation.